NOVOCART 3D PLUS (N3D) Study
Research type
Research Study
Full title
A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee.
IRAS ID
151121
Contact name
Vipul Mandalia
Contact email
Sponsor organisation
TETEC – Tissue Engineering Technologies – AG
Eudract number
2011-005798-22
Clinicaltrials.gov Identifier
Research summary
Summary of Results
A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee Internal Study No.: AAG-G-H-1202 EudraCT No.: 2011-005798-22 Lay report based on Final (5-Year) Analysis Report Final Version 1.0, 16-Oct-2023 Articular cartilage defects of the knee can cause considerable pain and disability. If left untreated, cartilage defects can lead to the onset of degenerative osteoarthritis and sooner or later it will advance to a level where total joint replacement becomes necessary.
The aim of this trial was to find out whether matrix-associated autologous chondrocyte implantation (M-ACI) with NOVOCART® 3D plus worked better than the standard treatment microfracture in patients with small- to mid-size cartilage defects of the knee (defect size: 2 – 6 cm2).
M-ACI is a 2-step surgical procedure. In a first step some cartilage is taken from a non-weight bearing area of the knee and sent to a laboratory for implant production. In a second surgical intervention, the patients’ own cells are implanted with a specific carrier matrix. Microfracture is a one-step surgical procedure where small holes are drilled in the bone underneath the cartilage defect which causes blood and cells to enter from the bone marrow into the defect to form a repair tissue.
In this trial patients were randomly put into 1 of 2 groups by a computer. This is called randomisation. 177 patients were treated by NOVOCART® 3D plus and 85 patients by microfracture.
The researchers looked at improvement of knee function and symptoms at different timepoints up to 5 years after surgery. In both study groups the knee function and symptoms had clearly improved over time with no relevant differences between groups. The only notable difference was that the proportion of patients who substantially improved their ability to participate in sports and recreational activities was higher in patients treated with NOVOCART® 3D plus (76.9%) than in patients with microfracture (56.3%).
There was little difference between side effects of NOVOCART® 3D plus and microfracture. The most common side effects in both study groups were knee pain, joint effusion and swelling, which are typical side effects of knee surgery.
The trial team concluded that for patients with small to mid-size cartilage defects of the knee, NOVOCART® 3D plus works just as well as microfracture in improving knee function and symptoms over a time-period of 5 years.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/0112
Date of REC Opinion
19 May 2014
REC opinion
Further Information Favourable Opinion